Enabling excellence to quality
- 1. Enabling Excellence to Quality Quality is the foundation of any business relationship Quality is a shared responsibility within an organization Quality is related to process and data Ryan Chen
- 2. Cut Through the Clutter and Focus There is never enough time for everything, but there is plenty of time for focus … 1. Prevention 2. Consumer focus 3. Process capability 4. Process control 5. Variation reduction 6. The Pareto principle 7. (Breakthrough improvement)
- 3. Prevention - 1 It is about eliminating opportunities for error. Prevention means successfully applying appropriate tools and processes to prevent the occurrence of defects, errors, and waste …
- 4. Prevention - 2 It is about eliminating cost associated with poor quality, and minimizing the total cost of quality … Prevention cost – “The Good” 1. Strategic and business planning for quality 2. Developing quality requirements and specifications 3. Developing quality measurements and goals 4. Education and training 5. Design reviews 6. Product qualification 7. New supplier quality evaluations 8. Process capabilities studies 9. Process control 10 . Preventive maintenance
- 5. Prevention - 3 Appraisal cost – “The Bad” 1. Incoming, in-process, and final inspection and test 2. Product quality audits 3. Maintenance of inspection equipment 4. Materials and supplies for inspection 5. Processing and reporting on inspection data 6. Evaluation of stock for degradation 7. Status measurement and reporting
- 6. Prevention - 4 Internal failure cost – “The Ugly” 1. Scrap, including related labor, materials, and overhead 2. Rework to correct defectives 3. Re-inspection of reworked products 4. 100% sorting inspection for defectives 5. Engineering changes to correct a design error 6. Manufacturing process changes to correct deficiencies 7. Scrapping of obsolete product 8. Difference between normal price & reduced price due to quality 9. Unplanned downtime due to quality failures 10. Inventory shrinkage 11. Non-value-added activities
- 7. Prevention - 5 External failure cost – “The Very Ugly” 1. Defective returns 2. Complaint handling 3. Warranty charges 4. Product recalls 5. Product liability lawsuits 6. Allowance made to customer due to substandard product 7. Profit margin lost due to customer defection for quality The strategy must be to continually reduce the total cost of quality by investing resources in prevention …
- 8. Prevention - 6 The root cause of most errors can be classified as either lack of knowledge or lack of attention checklist Pre-control
- 9. Prevention - 7 Anticipate and eliminate potential failures FMEA – Failure modes and effects analysis How component / process can fail; Determine how that failure will affect the quality/function of product; Develop strategic partnerships The attitude and behavior of the supplier’s top management; Measure supplier’s performance (quality/delivery), and maintain it Quality plan – flow chart, FMEA, control plan, control chart, Cpk, calibration, preventive maintenance, MSA, CAPA, housekeeping; Share information, identify & control risk during design & production
- 10. Customer focus It is all about building consumer loyalty Earn and keep consumer loyalty 1. Spec. must be consumer focused. 2. Requirement shall be adequately communicated and fully understood. Build brands, not commodities go beyond industry standards will result in delighting the consumer and differentiating your product from others.
- 11. Process Capability - 1 Maintain balance and control with precise, timely adjustments The tightrope walker need to make body- position adjustments to maintain balance. A Type 2 error occurs when a “special cause” change occurs but no action is taken. When a gust of wind comes up ... A Type 1 error occurs when there is not a special cause of variation (change), but action is taken because a change is imagined. To prevent neglecting the process To prevent tampering with the process
- 12. Process Capability - 2 Define and document the process People (operator) Material (components) Methods (SOP/SIP) Equipment (parameter) Measurement (GR&R) Environment (ESD) Inputs Process Output * ESD: Electro-Static Discharge * GR&R: Gage Repeatability & Reproducibility
- 13. Process Capability - 3 Measure and Verify Process Capability Cp (capability of process) = specification width / process width (6σ) Cp is a good measure of process capability only when the process is centered. A process is centered when the process mean is equal to the specification target.
- 14. Process Capability - 4 Measure and Verify Process Capability Cpk = Min ((USL-Means), (Means-LSL)) / half of process width (3σ)
- 15. Process Capability - 5 Control Accuracy and Precision Accuracy - how close an observed value is to the true value Precision is the characteristic of consistency and repeatability. Accuracy - Process mean Precision - process standard deviation Calibration for Accuracy Gage R&R for Precision Gage R&R evaluates the measurement variation (error) in a measurement system
- 16. Process Control - 1 Maintain balance and control with precise, timely adjustments A gust of wind body adjustments Type 2 error Type 1 error A Type 2 error occurs when a “special cause” change occurs but no action is taken. A Type 1 error occurs when there is not a special cause of variation (change), but action is taken because a change is imagined
- 17. Process Control - 2 Avoid Tampering and Neglect A gust of wind body adjustments Type 2 error Type 1 error Tampering - making an adjustment when without any special causes of variation. Neglecting - not making an adjustment when something has caused it to change Common causes are inherent in the process Special causes are not inherent in the process Special causes
- 18. Process Control - 3 Identify Critical Process Characteristics 20 percent (-) of the causes produce 80 percent (+) of the effect
- 19. Process Control - 4 Enforce Pre-control Charting the process output and taking the action indicated by results. Alert changes in process centering (mean) + process variation (σ) Four steps of pre-control Step 1: Set Up Pre-control Chart Zones The specification width is divided by 4 to create the pre-control zones Step 2: Qualify the Process Five consecutive units fall within the green zone; otherwise, the cause of the variation must be determined and reduced or eliminated
- 20. Process Control - 5 Enforce Pre-control Step 3: Begin Pre-control Charting After production begins, take two consecutive units every half-hour, record the results, and proceed according to the following rules: 1. If both units are in the green zone, continue production. 2. If one in green zone and the other in yellow zone, continue production. 3. If both in the same yellow zone, adjust the process + continue run. 4. If each unit falls into a different yellow zone, stop production, must determine, reduce or eliminate the cause of variation, then step 2 again. 5. If one or both units are in the red zone, stop production. must determine, reduce or eliminate the cause of variation, then step 2 again.
- 21. Variation Reduction - 1 Move from Zero Defects to Zero Variation Zero defects - the process output is in the Spec. tolerance limit.
- 22. Variation Reduction - 2 Move from Zero Defects to Zero Variation Zero variation - even though the process width is fully contained within the specification width, we will continue to reduce the variation..
- 23. The Pareto Principle -1 Focus on the vital few, not on the trivial many. Not All Problems Are Created Equal There are always the most important few, called the vital few, that account for the vast majority of cost or loss. The vital few problems are like the diamonds in the dirt, and our attention and efforts must be focused on them.
- 24. The Pareto Principle -2 From Causes to Vital Root Causes
- 25. The Pareto Principle -3 Place Importance Over Urgency – setting priorities